MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION®; DIMENSION® CYCLOSPORINE FLEX® REAGENT CARTRIDGE

Model Number	10285193
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Two (2) discordant falsely elevated cyclosporine a (csa) results were obtained on a patient sample on a dimension exl 200 system.One of the falsely elevated results was reported to the physician(s), and the result was questioned.The same sample was reprocessed on an alternate dimension exl 200 system, and the reprocessed result was considered correct.A corrected report was issued.There are no known reports of patient intervention or adverse health consequences due to the falsely elevated cyclosporine a (csa) results.
Additional Manufacturer Narrative
An outside of the united states (ous) customer contacted the siemens healthcare diagnostics remote services center (rsc) regarding two (2) falsely elevated cyclosporine a (csa) patient sample results obtained on a dimension exl 200 system.Siemens is investigating the event.
Additional Manufacturer Narrative
Additional information (09-jun-2023): siemens healthcare diagnostics headquarters support center (hsc) and technical operations (techops) concluded the investigation of the event.Hsc reviewed the attachment (photo) and the information provided by the customer.The attachment showed that the chromium oxide (cro2) tablet was attached to the top of the flex film and did not hydrate.The tablet being attached to the top of flex film could prevent the reaction from completing.Siemens healthcare diagnostics techops reviewed the information provided and concluded that a product non-conformance was not identified with the csa assay or the dimension exl 200 system.The event is consistent with a tablet hydration issue.The cause of the event is unknown.A potential product issue was not identified.The customer is operational.The device is performing within specifications.No further evaluation is required.Section h6 has been updated to reflect the siemens investigation.Initial mdr 2432235-2023-00132 was filed on 02-jun-2023.

• Brand Name: DIMENSION®
• Common Device Name: DIMENSION® CYCLOSPORINE FLEX® REAGENT CARTRIDGE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714 6101
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714 6101
• Manufacturer Contact: linda barletta ; 500 gbc drive; po box 6101; newark, DE 19714-6101
• MDR Report Key: 17049053
• Report Number: 2432235-2023-00132
• Device Sequence Number: 14325442
• Product Code: MKW
• UDI-Device Identifier: 00842768025136
• UDI-Public: 00842768025136
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K023065
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/14/2023
• Device Model Number: 10285193
• Device Catalogue Number: DF89A SMN 10285193
• Device Lot Number: FA3287
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/10/2023
• Supplement Date Received by Manufacturer: 06/09/2023
• Initial Report FDA Received Date: 06/02/2023
• Supplement Report FDA Received Date: 06/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/17/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown